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Senior Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Santa Clara
Posted on: March 10, 2023

Job Description:


  • Develop strategies to ensure the company's production activities comply with government regulations
  • Serve as a liaison between regulatory bodies and operating divisions of the company
  • Prepare and submit applications and reports to applicable regulatory agencies
  • Respond to requests for information from regulatory bodies
  • Coordinate with operations department regarding production design and development to ensure compliance with regulations
  • Assist with the development of standards for the company's operating and production procedures
  • Maintain current knowledge of regulations applicable to the company
  • Monitor regulatory affairs and the effect changes will have on company operations
  • Develop and maintain professional relationships in federal, state, and local regulatory agencies
  • Work closely with internal and external teams to ensure accurate implementation, compliance of designs


    • Bachelors/Master's Degree in Life Sciences or related field
    • 5+ years relevant experience in medical devices, preferable premarket devices
    • Experience in large company and/or start-up environment
    • Extensive knowledge of applicable government regulations
    • Ability to inform and educate managers and department heads on regulations and policies that require compliance
    • Demonstrated in-depth knowledge of ISO standards and systems
    • Demonstrated experience in implementation of Quality systems: US FDA 21CFR 820 QSR, IVDR, European MDR/MDD
    • Experience with Japanese PDMA is preferred, but not required
    • Medical Writing experience is preferred, but not required

Keywords: Katalyst Healthcares & Life Sciences, Santa Clara , Senior Regulatory Affairs Specialist, Other , Santa Clara, California

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